EU industry facing €80,000 fee for pharmacovigilance tasks
This article was originally published in Scrip
Executive Summary
In another manifestation of the changes being brought by the new EU pharmacovigilance legislation, companies marketing drugs in Europe are facing new fees of up to €80,000 for assessing post-authorisation safety studies (PASS) and periodic safety update reports (PSURs), not to mention a "service fee" of up to €1,000 a year for each product.